Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used wit
FDA device recall Z-0757-2016 · posted 2016-02-04 · Terminated
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared TJF-Q180V 510k.
- Action taken
- Olympus America Inc. sent an Urgent Notification letter dated January 15, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory for the affected product, Olympus will contact facilities to make arrangements for return of the TJF-Q180V duodenoscope(s) for the elevator mechanism replacement. For questions call (484) 896-5688.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- FDT
- Quantity affected
- 4436
- Distribution
- US Nationwide Distribution except PR
- Date initiated
- 2016-01-08
- Date posted
- 2016-02-04
- Date terminated
- 2017-01-09
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XTJF TYPE Q160VF1 (K080403) | Olympus Medical Systems Corporation | 2008-05-20 |